Ironwood Pharmaceuticals Announces Initiation Of Phase II Trial Of Linaclotide In Adult Patients With Opioid-Induced Constipation

Ironwood Pharmaceuticals, Inc.

announced today the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation (OIC). Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc, Ironwood's co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C (GC-C) agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linaclotide is not currently approved for the treatment of OIC. “Ironwood's pioneering research on the GC-C pathway led us to create the first and only FDA-approved GC‐C agonist, linaclotide. We believe a GC-C agonist could represent a different approach to the treatment of OIC, so we look forward to evaluating linaclotide in this category of constipation,” said Dr. Michael Hall, MB. BCh., senior vice president, clinical development of Ironwood. “This trial is designed to provide us with data on whether linaclotide can increase bowel movement frequency and impact other symptoms in adult OIC patients.” The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements (SBMs) per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.